Wilkes University Institutional Review Board

Application Cover Page

Complete this application and email as an attachment to:. We only accept electronic submissions.

The application should include (in one continuous document)

  1. A copy of the informed consent form.
  2. Evidence of Protecting Human Subjects training (certificate or other documentation of completion).
  3. A copy of any written test instruments including questionnaires, surveys, or interview instruments
  4. A copy of any audio, video, or other visual materials (pictures) used to test or measure responses of participants. (Actual audio or video materials should be sent to the emailaddresses above noted or mailed to the address indicated in the section “H” below.)
  5. Any additional materials that may aid the IRB in making its decision.

General Information:

  1. Date Submitted:

  1. Title of Project:

  1. Principal Investigator:

  1. Position:
Faculty
Staff
Student: Undergraduate; Masters; or Doctoral
Other (specify):
  1. If Student: Name and Email address of Faculty Sponsor:

  1. Departmentor Wilkes Affiliation:

  1. Address:
    City: State: Zip Code:

  1. Email:

  1. Phone Number:

  1. Is this research supported by external funding?: (Yes or No)

  1. If Yes, provide name of research sponsor:

  1. If student research, check all the apply
    Course requirement
Thesis
Independent research
Dissertation
Scholarly project
Other :______
  1. Type of Study: ______

  1. List additional investigators indicating their institution, department or position, and contact information. ______

As the principal investigator, my signature testifies that I have read and understood the University Policy and Procedures for the Use of Human Subjects in Research. I acknowledge that all procedures performed under this project will be conducted as outlined in the Research Proposal Application and that any modification to this protocol will be submitted to the committee in the form of an amendment for its approval prior to implementation.

Principal Investigator:

*
(typed/printed name) / (signature) / (date)

As the faculty sponsor, my signature testifies that I have reviewed this application thoroughly and will oversee the research in its entirety. I hereby acknowledge my role as theprincipal investigator of record.

Faculty Sponsor:

**
(typed/printed name) / (signature) / (date)

* Electronic submissions to the IRB are considered signed via an electronic signature

** For student submissions this signifies that the faculty sponsor has reviewed the proposal prior to it being submitted and is copied on the submission.

Wilkes University

Institutional Review Board for the Use of Human Subjects in Research

Research Proposal Application

Address each of the topics outlined below. If a topic is non-applicable to the proposed research, type N/A in the box. Every application for IRB review must contain complete information or delays in reviewing/processing the application may result.

A.SUMMARY OF RESEARCH PROJECT

In non-technical terms, provide a concise summary of the research project.

  • Briefly describethe purpose of the research and why it is important.
  • Where applicable include citations from the literature.
  • Include the main hypothesis, research question, or query that the research is designed to address
  • NOTE: detailed procedures are addressed in section “C” below

.

B. DESCRIPTION OF PARTICIPANTS

  1. How many participants will be involved in the research?
  1. Describe how participants will be recruited. Please provide the IRB with any recruitment materials that will be used.
  1. List specific eligibility requirements for participants. Describe screening and/or sampling procedures. Include criteria that would exclude otherwise acceptable participants and explain the rationale for the exclusion of potential participants.
  1. Disclose any relationship between researcher and participants --such as, teacher/student; employer/employee.
  1. Check any vulnerable populations targeted , included by chance (incidental), or not applicable (n/a) in your study:

Minors (under age 18) - if so, have you included a line on the consent form for the parent/guardian signature

targeted incidental n/a

Fetuses

targeted incidental n/a

Pregnant Women

targeted incidental n/a

Persons with mental, psychiatric or emotional disabilities

targeted incidental n/a

Persons with physical disabilities

targeted incidental n/a

Economically or educationally disadvantaged

targeted incidental n/a

Prisoners

targeted incidental n/a

Elderly

targeted incidental n/a

Students from a class taught by principal investigator

targeted incidental n/a

Other vulnerable population.

targeted incidental n/a

Provide the rationale for including any participants from a targeted Vulnerable Population. Include the approximate age range of any minors to be involved.

Provide the rationale for including any participants from an incidental Vulnerable Population. Include the approximate age range of any minors to be involved.

C.PROCEDURES (Methodology)

In non-technical language, describe procedures to be followed during the course of this research project in detail sufficient for the IRB to assess potential risks to participants. You should include:

  1. Descriptions of procedures, tasks, tests, etc. for all participants. If the project involves more than one group, provide descriptions for each group.
  1. Any interactions (e.g. between the participants and the researcher, participants and a third party).
  1. The time commitment for each participant.

D.RISKS AND BENEFITS

Include the following information (all five points must be addressed):

  1. The potential risks (physical, psychological, financial, social, legal or other) to participants and explain the steps taken to minimize these risks.
  1. Any request for information that might be considered personal or sensitive (e.g. private behavior, economic status, sexual issues, religious beliefs, or other matters that if made public might impair their self-esteem or reputation or could reasonably place the subjects at risk of criminal or civil liability)? Explain the steps taken to minimize these risks.
  1. Any procedures that might produce stress or anxiety, or be considered offensive, threatening, or degrading? Describe why they are important and what arrangements have been made for handling an emotional reaction from a participant.
  1. Any deception of the participants involved in this study? Describe why it is necessary and describe the debriefing procedures that have been arranged.
  1. What, if any, direct benefit is to be gained by the subjects? If no direct benefit is expected, but indirect benefit may be expected (knowledge may be gained that could help others), please explain.This does not include any form of compensation for participation.

E.HANDLING OF THE DATA

  1. To protect the confidentiality of the participants, describe how the data will be recorded and safely stored. Including information stored on electronic devices. How long will data be kept? (Note OHRP requirements 45 CFR 46 requires research records to be retained for at least 3 years after completion of the research.

2Describe how identifiers will be used in study notes, reports and other materials. (e.g. in the aggregate or individual)

3 If audio or videotaping is done, describe how the tapes will be stored and for how long.

4 Provide a list of anyone besides the PI or the research team who will have access to the data. Provide a rationale.

F.COMPENSATION

Complete this section if you intend to provide compensation to participants for taking part in your study.

  1. Describe the compensation.
  1. Explain compensation provisions if the participant withdraws prior to completion of the study.
  1. For student participants, if class credit will be given, list the amount and alternative ways to earn the same amount of credit.

G.CONFLICT OF INTEREST

Investigators seeking IRB review are required to indicate if the research protocol is subject to bias due to conflicting financial interests or other personal or professional situations of the investigator or the investigator’s team members who are involved in the study. The conflict of interest statement provides the investigator with the opportunity to describe how potential conflicts of interest are managed or prevented.

1. Do you have a significant financial interest in this project? Yes | No
If yes, you must complete the Wilkes University Significant Financial Interest Disclosure Form and paste it into the text box below.

2. Do you have any other significant conflict of interest? Yes | No
If yes, please explain and include a plan for managing the conflict(s).

H.INFORMED CONSENT AND OTHER REQUIRED INFORMATION

  1. Explain the process for obtaining informed consent.(AT THE END of this applicationattach a copy of informed consent. Please cut and paste as a Microsoft Word document.)

Cut and paste a copy of each relevant document in the boxes below.

  1. A copy of the informed consent form, addressing the following elements:
  1. Evidence of Protecting Human Subjects training (certificate or other documentation of completion). Training on protecting human research participants is required for students and faculty. Training is available for free from NIH at the link below. Evidence of training must be provided with this application. Each certificate of training is filed in the IRB office and is valid for three years.
  1. A copy of any written test instruments including questionnaires, surveys, or interview instruments
  1. A copy of any audio, video, or other visual materials (pictures) used to test or measure responses of participants. In the case of audio or video materials, send a copy to Wilkes University IRB/Attn: Provost Office, Wilkes University, 84 W. South Street, Wilkes-Barre, Pa. 18766 and indicate on your application that it is being mailed.
  1. Any additional materials that may aid the IRB in making its decision.

Wilkes University IRB Application 2010

revised March 2015Page 1